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Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01262586
First received: December 16, 2010
Last updated: May 3, 2012
Last verified: May 2012

December 16, 2010
May 3, 2012
November 2010
March 2011   (final data collection date for primary outcome measure)
Change in Glycemic profiles between vildagliptin and glimepiride [ Time Frame: Baseline and treatment Day 5, 24hr continuous glucose measurements ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01262586 on ClinicalTrials.gov Archive Site
Glucose Fluctuation before and during treatment [ Time Frame: Baseline and treatment Day 5, 24hr continuous measurements ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device

This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type II Diabetes Mellitus
  • Drug: Vildagliptin
  • Drug: Glimepiride
  • Experimental: Vildagliptin
    Intervention: Drug: Vildagliptin
  • Active Comparator: Glimepiride
    Intervention: Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes patients on stable metformin
  • 18-70 years old
  • Willing to perform at least 4 capillary blood glucose tests per day

Exclusion Criteria:

  • Type 2 diabetes patients on any other antidiabetic treatment
  • Patients listed in other trials
  • Patients with significant diabetic organ disease or complications.

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01262586
CLAF237A23151, 2010-021236-34
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP